Infringement of U.S. Patent No. RE44,186 ("Cyclopropyl-Fused Pyrrolidine-Based Inhibitors of Dipeptidyl Peptidase IV and Method," issued April 30, 2013) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of AstraZeneca's Onglyza® (saxagliptin hydrochloride, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus). View the complaint here.

The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 5,665,772 ("O-alkylated Rapamycin Derivatives and Their Use, Particularly as Immunosuppressants," issued September 9, 1997), 6,004,973 ("Pharmaceutical Compositions Comprising Rafamycin Coprecipitates," issued December 21, 1999), 6,239,124 ("Pharmaceutical Compositions for the Treatment of Transplant Rejection or Autoimmune or Inflammatory Conditions Comprising Cyclosporin A and 40-0-(2-hydroxyethyl)-rapamycin," issued May 29, 2001), and 6,455,518 ("Pharmaceutical Compositions for the Treatment of Transplant Rejection, Autoimmune or Inflammatory Conditions Comprising Cyclosporin A and 40-O-(2-hydroxyethyl)-rapamycin," issued September 24, 2002) following a Paragraph IV certification as part of Ben Venue's filing of an ANDA to manufacture a generic version of Novartis' Zortress® (everolimus, used for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant, and for the prophylaxis of allograft rejection in adult patients receiving a liver transplant). View the Delaware complaint here.

Infringement of U.S. Patent No. 8,288,434 ("Topical Pharmaceutical Formulations Containing a Low Concentration of Benzoyl Peroxide in Suspension in Water and a Water-Miscible Organic Solvent," issued October 16, 2012) and 8,663,699 ("Topical Pharmaceutical Formulations Containing a Low Concentration of Benzoyl Peroxide in Suspension in Water and a Water-Miscible Organic Solvent," issued March 4, 2014) following a Paragraph IV certification as part of Taro's filing of an ANDA to manufacture a generic version of Dow's Acanya® (clindamycin phosphate and benzoyl peroxide gel, 1.2%/2.5%, used to treat acne). View the complaint here.

Infringement of U.S. Patent Nos. 7,700,645 ("Pseudopolymorphic Forms of a HIV Protease Inhibitor," issued April 20, 2010), 7,126,015 ("Method for the Preparation of Hexahydro-furo-[2,3-b]furan-3-ol," issued October 24, 2006), 7,595,408 ("Methods for the Preparation of (3R,3aS,6aR)hexahydro-furo[2,3-b]furan-3-ol," issued September 29, 2009), and 8,518,987 ("Pseudopolymorphic Forms of a HIV Protease Inhibitor," issued August 27, 2013) following a Paragraph IV certification as part of Cipla's filing of an ANDA to manufacture a generic version of Janssen's Prezista® (darunavir, used to treat human immunodeficiency virus (HIV-1) infection). View the complaint here.

UCB, Inc. v. Yeda Research and Development Co. Ltd.
1:14-cv-01038; filed August 13, 2014 in the Eastern District of Virginia

Infringement of U.S. Patent No. 8,791,270 ("Bendamustine Pharmaceutical Compositions," issued July 29, 2014) in conjunction with Eagle's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Cephalon's Treanda® (bendamustine hydrochloride, used to treat chronic lymphocytic leukemia and non-Hodgkin's lymphoma). View the complaint here.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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